US-based device company AngioDynamics has received 510k clearance from the US Food and Drug Administration (FDA) for its AlphaVac F1885 system to treat pulmonary embolism (PE).
The AlphaVac MMA F1885 System, an emergent first-line device, is currently approved to remove thromboembolisms from the venous system. It features an ergonomic handle, an obturator, an 18F cannula with an 85° angle and a waste bag assembly.
The approval is based on positive data from the APEX-AV study, which met the primary endpoint of reduction in RV/LV [right ventricle–to–left ventricle] ratio between baseline and 48 hours post-procedure.
AngioDynamics started the study in collaboration with the Pulmonary Embolism Response Team (PERT) Consortium, which also met its primary safety endpoint of the rate of major adverse events (MAEs), including major bleeding, pulmonary vascular injury, and cardiac injury, within the first 48 hours.
A PE is a serious medical condition where a blood clot forms in a blood vessel in the lungs, typically originating from the deep veins in the legs, known as deep vein thrombosis (DVT). This blockage can be life-threatening, causing a cardiac arrest or stroke. According to a report on GlobalData’s Pharma Intelligence Center, the venous thromboembolism market, which includes DVT and PE, will generate $11.8bn in global sales by 2032.
Earlier this year, AngioDynamics completed the sale of its peripherally inserted central catheter (PICC) and Midline product portfolios to Spectrum Vascular for a sum of up to $45m. This sale was part of the company’s ongoing efforts to optimise its portfolio and restructure its manufacturing footprint.
In the announcement accompanying the approval, University of California Los Angeles (UCLA) interventional radiology professor John Moriarty said: “Catheter-based therapies are becoming a major tool in the PE space. With a handle that can limit blood loss and a true large bore cannula with a 33Fr funnel, I expect the AlphaVac System to play a crucial role in the treatment of PE.”
The California-headquartered Endovascular Engineering (E2) treated the first subject in the pivotal phase of its ENGULF US clinical trial of the Hēlo PE Thrombectomy System earlier this year to treat patients with PE.
